Kornimate/medical-research-clean huggingface dataset:
the efficacy of rehacop program in schizophrenia

Conditions: Schizophrenia

Summary: this study examined the efficacy of an integrative cognitive remediation program (rehacop) to improve cognition, social cognition, clinical symptoms and functional outcome in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnostic criteria for schizophrenia according to american psychiatric association's diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) exclusion criteria: * evidence of alcohol or drug abuse in the last 30 days * previous history of significant lack of consciousness * mental retardation * relevant neurological or medical condition
tissue adhesive vs. sterile strips after cesarean delivery

Conditions: Wound Complication; Complications; Cesarean Section

Summary: the goal of this project is to identify a strategy to reduce wound complications in women who undergo cesarean delivery by pfannenstiel skin incision. currently, many pfannenstiel skin incisions are closed by subcuticular sutures followed by either placement of sterile strips or tissue a\\adhesive. either sterile strips or tissue adhesive can be placed over the wound as a covering but it is unclear which may reduce wound complication rates. the hypothesis of this study is that tissue adhesive will result in a reduction in wound complication rates when compared to sterile strips. previously published studies in non-obstetric populations have identified tissue adhesive as a potential intervention to reduce wound complications. the eligible population for this study will include women at northshore university healthsystem evanston hospital and university of chicago hospital who will undergo primary or repeat cesarean delivery via pfannenstiel skin incision. women in the study will be randomized to receive either sterile strips or tissue adhesive. the primary outcome to be evaluated will be a composite of wound complication which will include drainage, cellulitis, hematoma, seroma and/or wound separation (partial or complete). secondary endpoints to be investigated include cosmetic outcome, patient satisfaction, cost comparison, and difference in operative times.


Eligibility criteria:
inclusion criteria: * women undergoing pfannenstiel cesarean delivery exclusion criteria: * inability to provide informed consent in english * planned use of staples for skin closure * unavailability of research personnel to accomplish consent and randomization at the time of cesarean
support for the rhabdomyolysis in an emergency department

Conditions: Rhabdomyolysis

Summary: rhabdomyolysis is a common condition in the uaa. support is heterogeneous, it is in most cases a mass hyperhydration. the idea is to initially with an epp simultaneously screened for the most affected by this disease and aggravating factors population, associated comorbidities. the rhabdomyolysis prognosis depends mainly on the etiology and associated comorbidities. * acute renal failure and hyperkalemia are the major complications that worsen the prognosis. * in most cases, acute renal failure is reversible. acute renal failure caused by renal vasoconstriction with ischemia, precipitation of myoglobin in the tubules and direct cytotoxic action of myoglobin. if the prime mover of rhabdomyolysis is ischemia (or hypoxia) cell, we now know that the tissue damage is greatly aggravated during muscle reperfusion, creating ischemia-reperfusion. reperfusion will not only cause the release into the bloodstream of the cell contents myocytes but also an increase in necrotic areas. indeed, the massive arrival of oxygen at the myocyte will cause significant production of free radicals, increasing their toxic effects. predictive factors of acute renal failure is creatinine and urea. the urine alkalinisation by bicarbonates is questionable oral alkalizing seems to be an alternative when possible (oral alkaline solution) but not used to this day. the track n-acetyl cysteine as an antioxidant that can possibly have an effect on release of the free radicals during reperfusion by decreasing their toxicity is still not considered clinically.

main objective / secondary: evaluation of current professional practice: i. identify the most common etiologies encountered in our sau. ii. identify the / types of people most affected by this disease iii. detect the most common complications of h0 support and evolution h48 if the patient not transferred iv. evaluate the emergency treatment at the initial charge. methodology : design: it is a non-interventional retrospective single-center study, within the department of emergency ghpsj, to an epp and output the results regarding the type of population most affected by this disease with the most common etiologies in our support (what we are doing). time study: study on patient records being passed on to the emergency 12 months out with a diagnosis of rhabdomyolysis.

Eligibility criteria:
inclusion criteria: * all adults with cpk greater than 5n or 500 iu / l in sera to emergencies exclusion criteria: * no exclusion criteria
tetriccad crown clinical study

Conditions: Fractured Tooth; Decayed Tooth; Unsatisfactory Restoration of Tooth

Summary: this investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. the material has been approved by the fda for patient treatment. a computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. the purpose of the study is to measure how well the high strength crowns function over an extended period of time.

the study will be composed of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. a maximum of two crowns per patient will be completed. all the crowns will be made from the same resilient ceramic cad/cam block(tetric cad/ivoclar vivadent). the crowns are placed using an adhesive bonding process including a total etch process with a universal adhesive (adhese by ivoclar vivadent) and dual-cured resin cement (variolink esthetic by ivoclar vivadent). the crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. at each appointment, an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

Eligibility criteria:
inclusion criteria: * must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar * reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration * teeth to be vital and asymptomatic prior to treatment * no more than two restorations will be placed per patient. if a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth. exclusion criteria: * devital or sensitive teeth * teeth with prior endodontic treatment of any kind * teeth with a history of direct or indirect pulp capping procedures * patients with significant untreated dental disease to include periodontitis and rampant caries * pregnant or lactating women * patients with a history of allergies to any of the materials to be used in the study * patients unable to return for the recall appointments

Keywords: crown ceramic cad/cam
promoting utilization and safety of hydroxyurea using precision in africa

Conditions: Sickle Cell Anemia in Children; Sickle Cell Disease

Summary: sickle cell anemia (sca) is among the world's most common and devastating blood disorders, affecting more than 300,000 newborns per year. most infants with sca are born in the low-resource settings of sub- saharan africa, where an estimated 50-90% will die before 5 years of age due to lack of early diagnosis and appropriate care. hydroxyurea is a safe and effective once-daily oral medication that has become the standard of care for the treatment of children with sca in high-resource settings. there is now a growing body of evidence to support the safety and clinical benefits of hydroxyurea for the treatment of sca in sub-saharan africa. the requirement for frequent laboratory monitoring, uncertainties about appropriate, most effective dosing, and the concern for hematologic laboratory toxicities, however, will continue to limit widespread hydroxyurea utilization and real-world effectiveness. the investigators have recently developed and prospectively evaluated an individualized, pharmacokinetics-guided hydroxyurea dosing strategy for children with sca that has demonstrated optimal clinical and laboratory benefits with minimal toxicity. in this research study, the investigators aim to extend this precision medicine approach to africa.

the promoting utilization and safety of hydroxyurea using precision in africa (pushup) trial is a prospective, randomized clinical trial of hydroxyurea for 400 children with sca in luanda, angola. the study will prospectively evaluate the safety and efficacy of hydroxyurea with limited laboratory monitoring and will bring precision medicine to children with sca using several novel features including measurement of hydroxyurea using a battery-powered hplc machine and individualized dose calculations using an automated computer-based algorithm. the objective of this study is to establish evidence-based guidelines for hydroxyurea in sub-saharan africa, including appropriate dosing and laboratory monitoring strategy with the goal of allowing for widespread use of hydroxyurea across sub-saharan africa, regardless of clinical or laboratory resources.

Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell anemia (hbss or hbs/b0-thalassemia) * age 6 months- 12 years of age at enrollment * parent or guardian willing and able to provide written or informed consent * weight ≥ 7.5 kg (temporary exclusion) exclusion criteria: * splenomegaly with evidence of hypersplenism as defined by platelet count \<150,000, hemoglobin \<5 g/dl or absolute neutrophil count \<1.0 x10\^9/l * hydroxyurea use within the past 6 months * blood transfusion within the past 6 months (temporary exclusion) * pregnancy * pre-existing severe hematologic toxicity, as defined by platelet count \<80,000, hemoglobin \<4 regardless of anc; hemoglobin \<6 and arc \<100; hemoglobin \<7 and arc \<80 x10\^9/l (temporary exclusion)
fecal microbiome transplant

Conditions: Clostridium Difficile; Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis

Summary: fecal microbiota transplant (fmt) in pediatric patients with recurrent c. difficile with or without inflammatory bowel disease (ibd) the aims of this study are to determine the safety and efficacy of fmt treatment in pediatric patients with recurrent or moderate to severe c. difficile without (through an observational study) and with (through a clinical trial) inflammatory bowel disease and to determine the effect of fmt on the gut microbiota through the use of 454 pyrosequencing before and after transplantation in these patients.


Eligibility criteria:
inclusion criteria: 1. diagnosis of inflammatory bowel disease by colonoscopy, radiographic and clinic measures, as per standard protocol. 2. age ≥ 3 years old. 3. recurrent c. difficile or moderate to severe c. difficile. 4. satisfactory completion of the medical interview and physical exam conducted by a study team member 5. participants must be between 3 and 21 years of age (inclusive) 6. signed informed consent form, and assent (if applicable) exclusion criteria: 1. patients \<3 years old 2. patients with other co-morbid intestinal infectious processes 3. recipients with a history of severe (anaphylactic) food allergy 4. if female, participants of childbearing potential (females aged 11 and older or those who have already begun menstruating) will be required to have a urine pregnancy test on the day of the fmt procedure. patients who are pregnant will not be enrolled. 5. patients with severe ibd. 6. ongoing/anticipated antibiotic use for non-cdi indication 7. adverse event attributable to a previous fmt 8. patients with allergies to sodium chloride or glycerol, both ingredients generally recognized as safe (gras) 9. any other condition for which the treating physician thinks the treatment may pose a health risk 10. predicted death within time period of follow-up 11. patients who are on supraphysiologic doses of corticosteroids

Keywords: fecal microbiota transplant
study on impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related pain

Conditions: Low Back Pain

Summary: the purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.

this study is a prospective, open-label, non-interventional study. the objective of the study is to investigate the impact of fentanyl matrix on improvement of pain and functioning after 8-week treatment of fentanyl matrix in the patients who complained of spinal disorder-related chronic pain in clinical practice according to the investigator's discretion. the primary endpoint is a percent of pain intensity difference between baseline and week 8 of the study. each patients will evaluate their pain intensity every 28 days during the 8 weeks. the secondary objectives are to observe the change in the following variables after administrating fentanyl matrix; k-odi (korean version - oswestry disability index) score, sleep disturbance, disturbance of activities of daily living and disturbance of social activities. in addition, investigator and patient global assessment, patient preference, cgi-i (clinical global impression - improvement) and adverse events will be investigated. ldk: lumbar degenerative kyphosis, crps: complex regional pain syndrome, fbss: failed back surgery syndrome observational study - no investigational drug administered

Eligibility criteria:
inclusion criteria: * patients who complain of spinal disorder-related chronic pain persisting for 3 months or longer * patients who can fully observe the overall clinical study requirements including k-odi completion at the investigator's discretion * patients who complain of severe pain (nrs score = 7) because pain was not treated enough with the previous analgesic * patients who have never been administered fentanyl matrix over the last one month exclusion criteria: * patients with a history of the drug or alcohol abuse in the past or now * childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.) * patients who are unable to use a transdermal system due to skin disease * patients with serious mental disorder * patients with history of hypersensitivity to opioid analgesics * patients with history of co2 retention * patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion

Keywords: chronic pain fentanyl matrix spinal disorder-related pain
long term study to investigate the efficacy & safety of d961h (esomeprazole) for the prevention of nsaids-induced ulcer

Conditions: Gastric Ulcer; Duodenal Ulcer; Rheumatoid Arthritis; Osteoarthritis; Lumbago

Summary: the purpose of this study is to assess the safety and tolerability of d961h (esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (nsaid) therapy by evaluating ae, clinical laboratory value and vital signs.


Eligibility criteria:
inclusion criteria: * medical history of gastric and/or duodenal ulcer * a diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily nsaid use,at least 20 years of age exclusion criteria: * having gastric or duodenal ulcer in active or healing stage according to the sakita/miwa classification * history of esophageal, gastric or duodenal surgery * having severe liver disease or chronic renal disease

Keywords: gastrointestinal gi nsaid japan japanese gastric ulcer duodenal ulcer
green tea in crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to assess whether green tea or coffee influence the course and life quality of patients with mild to moderately active crohn's disease.


Eligibility criteria:
inclusion criteria: * women and men ≥ 18 years with signed informed consent, * patients with proven crohn's disease, * chronic-active course ≥ 3 months, * current cdai ≥ 150 and ≤ 350, * all medications for crohn's disease have to be on a constant dosage for at least 4 weeks prior to study entry (i.e. 5-asa, steroids), * ability of the participant to understand character and individual consequences of the study. exclusion criteria: * pregnancy or the wish to become pregnant, breastfeeding, * concomitant treatment with methotrexate, azathioprine or 6-mercaptopurine for \< 3 months, * treatment with tnf-alpha-antagonists, cyclosporine or tacrolimus \< 4 weeks prior to study entry, * participation in another study within the last 4 weeks, * ulcerative colitis or indeterminate colitis, * infectious colitis, including cytomegalovirus or clostridium difficile induced colitis, * colitis for other reasons like known diverticulitis, radiation colitis, ischemic colitis or microscopic colitis, * malabsorption syndromes, lactose intolerance, celiac disease, exocrine pancreas insufficiency, * bleeding hemorrhoids, * other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding, * intolerance / aversion to tea and/or coffee, * current treatment with antibiotics.
chemoradiotherapy for advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: this study aims to show that the addition of carboplatin and paclitaxel chemotherapy to a palliative course of external beam radiation treatment improves both dysphagia relief and patient quality of life in patients with unresectable esophageal cancer.

patients with carcinoma of the esophagus not suitable for definitive radical treatment who have symptomatic dysphagia requiring locoregional palliation, and who have no contra-indications to chemo-radiotherapy will be offered carboplatin (auc 2) and paclitaxel (50 mg/m2) intravenously on days 1 and 8 concurrent with external beam radiation therapy of 30gy/10 fractions over two weeks where the primary goal is relief of dysphagia and other outcomes include toxicity, quality of life and metabolomics.

Eligibility criteria:
inclusion criteria: 1. biopsy proven carcinoma of the esophagus. 2. not a candidate for radical/curative treatment due to the advanced nature of the disease, presence of metastases, or intercurrent illness. 3. symptomatic patients with mellow dysphagia scores of ≥ 1 i.e. able to eat only some solids. 4. ecog performance status ≤ 2. 5. patients able to begin treatment within 14 days of signing the informed consent form. 6. patient is at least 18 years old. 7. hematological function as defined by the following laboratory parameters: * hemoglobin \> 100g/l * platelet count \> 100x10e9/l * absolute neutrophil count \> 1.5x10e9/l 8. renal function to undergo chemotherapy as defined by the following laboratory parameters: * aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 2.5x the upper limit of institutional normal (≤ 5 if liver metastases) * total bilirubin ≤ 1.5x the upper limit of institutional normal * calculated creatinine clearance ≥ 50 ml/min using the cockcroft-gault formula 9. patients capable of childbearing are using adequate contraception. 10. written and informed consent of patient. exclusion criteria: 1. previous radiotherapy delivered to the chest. 2. synchronous active malignancies. 3. pregnant or lactating patients: women of child bearing potential must have a negative serum pregnancy test within 7 days of treatment visit 1. women or men of child bearing potential must use effective contraception (defined by the use of two birth control methods, which can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy). subjects must start using birth control from the time they have signed the informed consent form prior to start of therapy until 120 days post completion of study therapy or study discontinuation, which must be documented in the ecrf. 4. patients unfit for any treatment component, including absolute contraindications for radiotherapy or connective tissue disease. 5. tracheo-esophageal fistula. 6. esophageal stents in situ. 7. previous chemotherapy for esophageal cancer 8. unable to complete surveys in english without aid of interpreter.
a trial of inflammatory markers, depressive symptoms, and heart disease

Conditions: Depression; Coronary Artery Disease (CAD); Acute Coronary Syndrome (ACS)

Summary: the purpose of this study is to examine the relationship between depressive symptoms and markers of inflammation, two predictors of heart disease.

depressive symptoms and inflammatory markers have both been proposed as measures that indicate/precede coronary artery disease (cad). however, no controlled research study has tested the impact of these two candidate cad risk factors within the same design to see the directionality of their influence. this study will explore if simvastatin reduces depressive symptoms and if sertraline reduces c-reactive protein (crp). additionally, the recruitment process will help determine the feasibility of a larger trial, powered for significance testing. three hundred and seventy-five participants will be consented and screened for this study. we expect forty-two otherwise healthy outpatients to have both elevated symptoms and high crp levels, and be willing to be randomly assigned to sertraline, an antidepressant, simvastatin, a drug with anti-inflammatory properties, or a placebo for 8 weeks. depressive symptoms and inflammatory indicators will be assessed before treatment (screening and baseline), mid-treatment (after 4 weeks), post-treatment (after 8 weeks), and a follow-up visit (after 12 weeks), using blood tests and depression interviews. we expect that both inflammation and depressive symptoms may be reduced by both medications, but the number of subjects needed to test this hypothesis is not yet known. hence, this pilot study will be conducted. knowledge about the inter-dependency of these two cad risk factors allows the most promising future observational/intervention studies to be designed and conducted.

Eligibility criteria:
inclusion criteria: 1. age 18 - 60 2. mild depression 3. inflammatory markers: crp \> 2 exclusion criteria: 1. non-english or non-spanish speakers 2. active suicidal or homicidal ideation 3. current alcohol or other substance abuse 4. psychotic features 5. current personality disorder 6. history of bipolar depressive disorder 7. any current psychotic disorder 8. current major depressive disorder 9. current depression treatment or treatment within preceding 6 weeks 10. history of chronic liver and/or renal disease 11. current use or contraindication to any of the tested medications 12. absence of a response to a previous adequate trial of any of the tested medications 13. pregnant or lactating women 14. history of coronary artery disease 15. current use of statins 16. current, regular aspirin use 17. antibiotic use within the previous four weeks 18. history of diabetes 19. inflammatory diseases 20. meets ncep guidelines for cholesterol lowering therapy

Keywords: depression inflammation heart disease randomized clinical trial sertraline simvastatin placebo